Job Description

An amazing opportunity has arisen as a Senior QA Specialist, this senior role leads a team in the site Quality team.

The Senior Quality Specialist (POD Lead) is a self-directed, decision maker who is responsible for the management and oversight of the Quality Management Systems in the Drug Substance and Drug Product Intermediate facilities and for the achieving the Quality deliverables in the Integrated Process Teams (IPTs) ensuring that the site meets all Manufacturer’s Licence requirements for clinical and commercial production and is audit ready for both customers and agency inspections. Uses sound judgement to make good decisions based on information gathered and analysed.

Responsible for providing leadership and guidance on site-wide quality assurance and regulatory compliance.

Bring energy, knowledge, innovation to carry out the following:

• Lead the Quality Specialist team to ensure timely and effective completion of the Quality IPT core functions, including:
• Application of Quality Risk Management to all process and systems.
• Production support and quality compliance guidance to ensure the facility meets and operates to all GMP requirements for development, clinical and commercial supply.
• Assist the IPT leadership team to deliver business results for the IPT in line with overall site goals.
• Documentation preparation, review & approval process required to support IPT operations.
• Prepare Annual Process and System Reviews.
• Raw material (API, SDI and excipient) and component release, targeting.
• Batch review and release and deviation management process.
• Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated CAPA identified.
• Provide support to deviation investigations and process performance monitoring. Perform trending on deviations raised as required to identify improvement initiatives.
• Provide detailed knowledge of quality systems and ensure that root cause is identified and corrective actions as appropriate are completed.
• Provide guidance on quality requirements to maintain validation status, including participation in process/product Risk Assessments.
• Deliver on System Improvements.
• Ensure changes controls raised are documented, assessed, and completed.
• Participate in the generation and communication of quality metrics.
• Preparation, review & approval of site documentation including policies, procedures, associated reports and annual reviews, as required to support site quality systems.
• Participation in the internal audit program.
• Participate in the preparation for and hosting of regulatory and customer audits.
• Participate in Quality and site projects that may arise including New Product Introduction.
• Participate as a team member in the site new product introduction teams established to manage the transition of new products from Phase II2 through to PPQ and supply.
• Delegate for the Associate Quality Director as required.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Degree or postgraduate qualification in Science, Pharmacy, or a related discipline.
• Experience with Quality IT systems (e.g., SAP, TrackWise, LIMS, QSAT, Quality Docs) is desirable.
• Knowledge and demonstrated expertise in Lean / Continuous Improvement.
• Proven leadership skills, including experience managing people and direct reports.
• Experience and knowledge of GMP requirements for electronic or paperless operations (MES).
• Project management experience is an advantage.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

Required Skills:

GMP Documentation, LabWare LIMS, Quality Information Systems, SAP CRM

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

12/6/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.